ORDER OF THE PRESIDENT OF THE GENERAL COURT
24 August 2018 (*)
(Interim relief — Regulation (EU) No 528/2012 — Biocidal products — Active substance PHMB (1415; 4.7) — Approval refused — Application for interim measures — Prima facie case — Weighing up of competing interests)
In Cases T‑337/18 R and T‑347/18 R,
Laboratoire Pareva, established in Saint-Martin-de-Crau (France), represented by K. Van Maldegem and S. Englebert, lawyers,
applicant in Case T‑337/18 R,
Laboratoire Pareva, established in Saint-Martin-de-Crau,
Biotech3D Ltd & Co. KG, established in Gampern (Austria),
represented by K. Van Maldegem and S. Englebert, lawyers,
applicants in Case T‑347/18 R,
v
European Commission, represented by R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,
defendant,
APPLICATION pursuant to Articles 278 and 279 TFEU seeking suspension of operation of Commission Implementing Decision (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6 (OJ 2018 L 102, p. 21) and Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1), and the adoption of any other appropriate interim measures,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought by the parties
1 The applicant in Case T‑337/18 R and first applicant in Case T‑347/18 R, Laboratoire Pareva (‘the first applicant’), is a producer of the substance Polyhexamethylene biguanide hydrochloride (‘PHMB (1415; 4.7)’) in the European Union.
2 The second applicant in Case T‑347/18 R, Biotech3D Ltd & Co. KG (‘the second applicant’), is a customer of the first applicant who produces PHMB (1415; 4.7)-based biocidal products and devices for disinfection and deodorising uses in the European Union.
3 On 20 April 2018, the European Union adopted Implementing Decision (EU) 2018/619 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6 (OJ 2018 L 102, p. 21) (‘the contested decision’).
4 It is apparent from recital 2 of the contested decision that PHMB (1415; 4.7) has been evaluated for use in biocidal products of product-type 1 (human hygiene), 5 (drinking water) and 6 (preservatives for products during storage).
5 Recital 3 of the contested decision states that the French Republic was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, on 13 December 2016.
6 According to recital 4 of the contested decision, the opinions of the European Chemicals Agency (ECHA) were formulated on 4 October 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
7 Recital 5 of the contested decision states that, according to those opinions, biocidal products used for product-types 1, 5 and 6 containing PHMB (1415; 4.7) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1). For those product-types, the scenarios evaluated in the human health and environmental risk assessments identified unacceptable risks.
8 Article 1 of the contested decision states that PHMB (1415; 4.7) is not approved as an active substance for use in biocidal products of product-types 1, 5 and 6.
9 The same day, 20 April 2018, the Commission adopted Implementing Regulation (EU) 2018/613 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1) (‘the contested regulation’).
10 It is apparent form recital 2 of the contested regulation that PHMB (1415; 4.7) has been evaluated for use in products of product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals) and product-type 4 (food and feed area).
11 According to recitals 4 and 7 of the contested regulation, the opinions of the ECHA, as formulated on 4 October 2017 by the Biocidal Products Committee, concluded that PHMB (1415; 4.7) meets the criteria for being a very persistent (vP) and toxic (T) substance and should be considered a candidate for substitution.
12 Article 1 of the contested regulation states that PHMB (1415; 4.7) is approved as an active substance for use in biocidal products of product-types 2 and 4, subject to the specifications and conditions set out in the annex to that regulation. It is apparent from the provisions of that annex that authorisations of biocidal products of product-types 2 and 4 are subject to various conditions and that the person responsible for the placing on the market of an article treated with or incorporating PHMB (1415; 4.7) is to ensure that the label of such an article complies with the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
13 On 1 June 2018, the first applicant lodged with the General Court Registry an application, registered as Case No T‑337/18, seeking, in essence, annulment of the contested decision.
14 The same day, by separate document lodged at the General Court Registry, the first applicant submitted an application for interim measures, claiming, in essence, that the President of the General Court should:
– suspend operation of the contested decision with immediate effect, pursuant to Article 157(2) of the Rules of Procedure of the General Court;
– grant any other interim measure as may be deemed appropriate and hold a hearing if deemed necessary;
– order the Commission to pay the costs.
15 In its observations on that application for interim measures, lodged at the General Court Registry on 21 June 2018, the Commission contends that the President of the General Court should:
– dismiss the application for interim measures;
– reserve the costs.
16 On 1 June 2018, the first applicant and the second applicant lodged an application with the General Court Registry, registered as Case No T‑347/18, seeking, in essence, annulment of the contested regulation.
17 On 5 June 2018, the first applicant and the second applicant lodged, by separate document filed at the General Court Registry, an application for interim measures, in which they claim, in essence, that the President of the General Court should;
– suspend operation of the contested regulation with immediate effect, in accordance with Article 157(2) of the Rules of Procedure;
– grant any other interim measure as may be deemed appropriate and hold a hearing if deemed necessary;
– order the Commission to pay the costs.
18 In its observations on that application for interim measures, lodged at the General Court Registry on 26 June 2012, the Commission contends that the President of the General Court should:
– dismiss the application for interim measures as inadmissible in so far as concerns the second applicant;
– dismiss the application for interim measures in so far as concerns the first applicant;
– reserve the costs.
19 On 26 June 2018, the President of the General Court requested the parties to express their views on a possible joinder of the cases for the purpose of the interim relief proceedings.
20 In response, the parties raised no objection to the cases being joined for the purpose of the interim relief proceedings.
Law
General considerations
21 It is apparent from a reading of Articles 278 TFEU and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order suspension of the operation of an act contested before the General Court or prescribe interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).
22 The first sentence of Article 156(4) of the Rules of Procedure requires applications for interim measures to state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.
23 Accordingly, the judge hearing an application for interim relief may order suspension of operation of an act, or other interim measures, if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also required to weigh up, when necessary, the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).
24 In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).
25 Having regard to the material in the case file, the President of the Court considers that he has all the information needed to rule on the present applications for interim measures, without there being any need first to hear oral argument from the parties.
Joinder of Cases T‑337/18 R and T‑347/18 R
26 Questioned by the President of the General Court, the parties did not raise any objection to the two interim relief applications being joined for the purpose of the present order.
27 Having regard to the fact that Cases T‑337/18 R and T‑347/18 R turn on very similar facts and have, in essence, the same subject matter, it is appropriate, pursuant to Article 68(1) of the Rules of Procedure, to order their joinder for the purpose of this order.
The requirement to establish a prima facie case
28 As a general rule, the prima facie case requirement is satisfied where at least one of the pleas in law put forward by the party seeking interim measures in support of the main action appears, at first sight, not unfounded. That is the case where one of the pleas relied on reveals the existence of difficult legal or factual issues the solution to which is not immediately obvious and therefore calls for a detailed examination that cannot be carried out by the judge hearing the application for interim measures and must be addressed in the main proceedings (see, to that effect, orders of 3 December 2014, Greece v Commission, C‑431/14 P-R, EU:C:2014:2418, paragraph 20 and the case-law cited, and of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 59 and the case-law cited).
29 Furthermore, under the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures must ‘contain all the evidence and offers of evidence available to justify the grant of interim measures’.
30 Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary without any other supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).
31 While the application for interim measures may be supplemented on specific points by references to documents annexed to the application, those documents cannot compensate for the failure to set out the essential elements in that application. It is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the information that may be found in the annexes to the application for interim measures, in the main application or in the annexes to that application, which is liable to substantiate the application for interim measures. To impose such an obligation on the judge hearing the application for interim measures would also be likely to deprive of all effect Article 156(5) of the Rules of Procedure, under which the application for interim measures must be made by separate document (see order of 20 June 2014, Wilders v Parliament and Others, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).
32 In the present case, the applicants rely on three pleas in law in support of their applications for annulment of the contested decision and the contested regulation (‘the contested measures’).
33 By their first plea, they allege substantive procedural errors in that the French Republic, as evaluating competent authority, infringed Article 6(7) of Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation No 528/2012 (OJ 2014 L 294, p. 1).
34 In the present case, the applicants maintain that, in accordance with Article 6(7)(a) of Regulation No 1062/2014, the evaluating competent authority should have submitted a harmonised classification and labelling proposal to the ECHA no later than the time the assessment report was submitted, that is, by 13 December 2016.
35 Similarly, the applicants argue, the evaluating competent authority should have consulted the ECHA, in accordance with Article 6(7)(b) of Regulation No 1062/2014, no later than the time the assessment report was submitted, that is, by 13 December 2016.
36 As those requirements were not complied with, the first applicant was denied the opportunity to be heard in that connection. If it had been able to submit its observations at that time, there may have been a different outcome from that imposed by the contested measures.
37 Prima facie, that line of argument does not appear to take sufficient account of the connection between the various procedures in question.
38 The contested measures were adopted by the Commission on the basis of Article 89(1) of Regulation No 582/2012 and of the ECHA opinion submitted to the Commission pursuant to Article 7(2) of Regulation No 1062/2014. That opinion was based, in turn, on the assessment report submitted by the evaluating competent authority to the ECHA, in accordance with Article 6(2) of that regulation.
39 It is in the context of that procedure that PHMB (1415; 4.7) was examined.
40 On the other hand, as regards the alleged breach of the requirements laid down in Article 6(7) of Regulation No 1062/2014, it appears, prima facie, that, according to the wording of that provision, the main purpose of the procedural requirements that must be complied with by the evaluating competent authority is to ensure that the lists to which that provision refers are updated, not to assess the substance in question, in the light of any comments that may be made by the applicants, for the purpose of deciding whether or not it may be approved.
41 Moreover, it should be noted that the applicants’ arguments are predicated on a whole range of assumptions. First, the assumption that there has been a breach of the requirements laid down in Article 6(7) of Regulation No 1062/2014. Second, the assumption that, if the evaluating competent authority had made a harmonised labelling and classification proposal and consulted the ECHA, the first applicant would have been given the opportunity to state its views — although it is not established under what provision the first applicant would have had such a right. Third, the assumption that the assessment under the procedure established by Article 7(2) of Regulation No 1062/2014 could have had a different outcome if the first applicant had been able to state its views in the procedures laid down in Article 6(7) of that regulation — although it is not established that the first applicant would thus have been denied the opportunity of stating its views to the committee which, prima facie, is competent in the present case, namely the ECHA Biocides Committee.
42 By their second and third pleas, which it is appropriate to consider together, the applicants allege manifest errors of assessment and breach of the rights of defence.
43 In that regard, they maintain, first, that the evaluating competent authority, the ECHA and the Commission failed to examine PHMB (1415; 4.7) in the light of its inherent characteristics, and carried out the examination by ‘consistently cutting and pasting’ the conclusions of the classification and risk assessment relating to another type of PMBH. Moreover, the applicants submit that, in any event, no justification was given as regards the application of the read-across approach.
44 In that connection, the applicants refer, by way of example, to three documents.
45 However, the documents to which they refer, namely an extract of the draft report of the evaluating competent authority of May 2016, an extract of the report of the evaluating competent authority of November 2016 and an email of the evaluating competent authority of 16 December 2016, do not substantiate, prima facie, the applicants’ claim that the evaluating competent authority, the ECHA and the Commission had ‘consistent’ recourse to the ‘cut and paste’ approach.
46 Indeed, it is not possible, a priori, to draw the conclusion from those documents that the evaluating competent authority had ‘consistent’ recourse to the alleged ‘cut and paste’ approach. In so far as reference is made to a read-across approach, whereby the results of studies relating to another type of PHMB are taken into account in evaluating PHMB (1415; 4.7), it cannot be concluded, prima facie, that such an approach is the same as the alleged ‘cut and paste’ approach, which, had it been used, might have been sufficient to establish a prima facie case.
47 A fortiori, since all the documents to which the applicants refer emanate from the evaluating competent authority, it is not possible to draw, prima facie, any conclusion from those documents as to whether, in examining the assessment report, the ECHA had ‘consistent’ recourse to the alleged ‘cut and paste’ approach.
48 Indeed, as regards the contested regulation, it should be noted that, according to the draft report produced by the evaluating competent authority, a recommendation was made not to approve PHMB (1415; 4.7) for product-types 2 and 4 and it was only in the course of the evaluation, carried out under the auspices of the ECHA, that that recommendation was altered. In those circumstances, it cannot be validly claimed that the ECHA adopted the evaluation of the evaluating competent authority without conducting a proper examination.
49 Furthermore, the final minutes WGIII2017_TOX_6-3 of 25 September 2017 refer to an extensive discussion, in which the first applicant participated, concerning the possibility of referring to data relating to another type of PHMB for the purpose of examining the inhalation acceptable exposure concentration in the absence of specific data for PHMB (1415; 4.7). The outcome of that discussion was that the members of that working group concluded, ‘on a scientific basis’, that the data relating to another type of PHMB could be used and that no additional safely factor was needed.
50 The process described above does not, prima facie, support the claim that, in so far as the data relating to another type of PHMB were used for the purpose of examining the inhalation acceptable exposure concentration, the ECHA simply had recourse to a ‘consistent cut and paste’ approach and is, instead, evidence of the fact that the ECHA, allowing the first applicant to state its views, analysed whether, in the circumstances of the case, a reference to such data was scientifically justified.
51 Second, the applicants submit that the evaluating competent authority, the ECHA and the Commission failed to take account of current relevant data provided by the first applicant in the course of the procedure.
52 It should be noted that the procedure introduced by Regulations No 582/2012 and No 1062/2014, under which the contested measures were adopted, takes place in several different stages.
53 Moreover, participation by the applicants in the procedure is regulated by specific rules.
54 Nevertheless, the applicants merely claim that no account was taken of ‘relevant and state-of-the-art data submitted by [the first applicant] (Annexes R9 to R16)’.
55 Thus, the applicants refer, as is apparent from Annexes R9 to R16, to a large number of documents which the first applicant submitted during the period from 22 April 2012 to 21 July 2017.
56 The applicants do not, however, specify at which point in the various stages of the procedure those documents were submitted, or whether they were submitted within the periods laid down in Article 6(4) of Regulation No 1062/2014 or those set by the evaluating competent authority pursuant to Article 6(5) of that regulation, or indeed whether those documents were requested by the authorities or were submitted voluntarily.
57 In accordance with the case-law cited in paragraph 31 above, it is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the information that may be found in the annexes to the application for interim measures, in the main application or in the annexes to that application, which is liable to substantiate the application for interim measures.
58 Accordingly, on the basis of the mere claim that ‘relevant and state-of-the-art data submitted’ by the first applicant was not taken into account and in the absence of any additional specific indications concerning the evidence referred to in paragraph 56 above, the judge hearing the application for interim measures is not in a position to examine whether the documents in question were or should have been taken into account.
59 Third, the applicants maintain that document WGIII_2017 _TOX_6-3a was provided to the first applicant only on 7 June 2017, that is, after the meetings of the working groups, and that it was not given any ‘insight’ into any of the documents ahead of the meetings of the working group concerned.
60 However, the applicants have not indicated how document WGIII_2017 _TOX_6-3a was relevant in the assessment procedure and have also failed to provide any information on the meetings of the working groups concerned or on the possible impact of the fact that the first applicant was not in possession of that document before 7 June 2017.
61 Similarly, it is not possible, on the basis of the applicants’ claim that they were entitled to an ‘insight into all of the documents’ before the meetings of the working groups, to determine the scope of such a right, which might encompass documents provided by third parties. In the absence of any indication as to the precise scope of such a right, the judge hearing the application for interim measures is not, a priori, in a position to recognise that right, to conclude prima facie that it has been infringed in the present case, or to assess, prima facie, the consequences of any failure to have due regard to such a right.
Weighing up of interests and urgency
62 According to case-law, the risks associated with each of the possible disposals of the case must be weighed in the proceedings for interim measures. In practical terms, that means examining whether or not the interest of the party seeking interim measures in obtaining suspension of the operation of the contested act outweighs the interest in its immediate implementation. In that examination, it must be determined whether the possible annulment of that act by the judgment on the substance would make it possible to reverse the situation that would have been brought about by its immediate implementation and, conversely, whether suspension of its operation would be such as to impede the objectives pursued by the contested act in the event of the main action being dismissed (order of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 127).
63 In the present case, the applicants submit that the weighing up of the interests tilts the balance in favour of suspending operation of the contested measures, whereas the Commission is of the view that it tilts in favour of refusing suspension.
64 As it cannot be ruled out that both suspension of operation of the contested measures and a refusal to suspend operation may have definitive effects, it is necessary to determine the interests to be taken into account in weighing up the interests.
65 According to the contested measures, unacceptable risks for human health and the environment have been detected in respect of the use of PHMB (1415; 4.7) for biocidal products of product-types 1, 5 and 6, that substance meets the criteria for being a very persistent (vP) and toxic (T) substance and should therefore be considered a candidate for substitution, and use of that substance in biocidal products of product-types 2 and 4 must be regulated by additional specifications and conditions.
66 The Commission concludes from this that the weighing up must start from the premiss that there is a risk for human health and the environment.
67 As regards the contested decision, the Commission refers to the findings made when PHMB (1415; 4.7) was examined.
68 According to the Commission, for product-type 1 (human hygiene), the human health risk assessment identified unacceptable risks for professional users (surgeons, nurses in hospitals using products containing PHMB (1415; 4.7) for hand disinfection), non-professional users (the general public at home) and toddlers putting their hands in their mouths. The environmental risk assessment identified unacceptable risks for sediments, soil and surface water when considering private and professional uses.
69 Moreover, the human health risk assessment for product-type 5 (drinking water) identified unacceptable risks for professional users linked to dermal contact with disinfected drinking water. The environmental risk assessment identified unacceptable risks for the aquatic compartment (including sediment) and soil.
70 Lastly, as regards product-type 6 (preservatives for products during storage), the human health risk assessment identified unacceptable risks for professional and non-professional users linked to dermal contact with detergents preserved with PHMB (1415; 4.7). Unacceptable risks were also identified for the general public as a result of wearing clothes washed with detergents containing such a preservative. The environmental risk assessment identified unacceptable risks for at least one environmental compartment (surface water, sediments, ground water and soil) in all scenarios assessed.
71 As regards the contested regulation, the Commission maintains that a number of unacceptable risks for human health and the environment were identified after a thorough evaluation of certain uses of product-types 2 and 4, some of them for vulnerable groups (toddlers).
72 On the other hand, the applicants do not expressly dispute the existence of a risk for human health or the environment.
73 The applicants simply state that PHMB (1415;4.7) does not pose ‘any problem of public health’.
74 Furthermore, the applicants state that ‘no major health issues have been identified with regard to the substance over the last 40 years’. In that connection, they refer to Section 9.0 of a report of the US Environmental Protection Agency.
75 It should be noted in that regard that the applicants have failed to establish the relevance of that report. Indeed, they have failed to establish that that report relates to PHMB (1415; 4.7) and not to another type of PHMB. Nor have they established that the report was prepared for similar purposes to those of the examination conducted under Regulation No 528/2012.
76 Moreover, Section 9.0 of that report simply sets out an incident report assessment and could not justify the conclusion, even if the report related to PHMB (1415; 4.7), that that substance does not pose ‘any problem of public health’. Indeed, it is apparent from the summary in Section 1.0 of that report that tests conducted on certain mammal species indicated that its toxicity and carcinogenicity.
77 Lastly, the applicants cannot, in order to eliminate any suggestion of risk for human health or the environment, draw any valid argument from the claim that PHMB (1415; 4.7) has been used safely in the United States and the European Union for many years. In the sector concerned by the present cases, scientific developments are not unusual and thus provide an opportunity for substances to be evaluated afresh in the light of newly acquired knowledge and new scientific discoveries. That is the basis of renewal procedures and the rationale for applying time limits to marketing authorisations (see, by analogy, order of 22 June 2018, FMC v Commission, T‑719/17 R, EU:T:2018:408, paragraph 97).
78 Accordingly, the weighing up of interests must start from the premiss that the restrictions on the use of PHMB (1415; 4.7) imposed by the contested measures promote protection of human health and the environment and, as a consequence, suspension of operation of the contested measures may pose a risk for human health and the environment.
79 With regard to the interests defended by the applicants, they claim that there is a risk of considerable loss of market share and even a risk of bankruptcy. The also claim that there is a risk of job losses.
80 Therefore, the risks for human health and the environment must be weighed against the risk of loss of market share, or even bankruptcy, and of job losses.
81 In that regard, it is established case-law that, in principle, the requirements relating to the protection of public health must unquestionably take precedence over economic considerations (see order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 112 and the case-law cited, and judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 99 and the case-law cited).
82 Thus, it remains to be verified whether the actual weighing up of the interests in the present case discloses elements that tilt the balance in favour of the interim measures sought by the applicants.
83 As regard the risk for human health and the environment, the applicants have not put forward any evidence that makes it possible to conclude with a sufficient degree of certainty that those risks are negligible or unlikely.
84 Moreover, according to Article 1 thereof, the purpose of Regulation No 582/2012 is, inter alia, to ensure a high level of protection for human health and the environment and its provisions are based on the precautionary principle.
85 In that regard, it should be noted that, according to that principle, where the existence or the extent of risks to human health is uncertain, the EU institutions, applying that principle laid, may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (see, to that effect, judgment of 19 December 2013, Commission v Germany, C‑426/13 P(R), EU:C:2013:848, paragraph 54 and the case-law cited).
86 The relevance of the interest in avoiding risks for human health and the environment is underlined by the fact that, pursuant to Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1), the Commission commenced at 10-year programme of work for the systematic examination of all active substances already on the market as active substances of a biocidal product.
87 In that context, the complete dossier for the examination of PHMB (1415; 4.7) should have been received by the evaluating competent authority, ‘no later than 31 July 2007’, according to Part C of Annex V to Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8, and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1).
88 However, according to the Commission, on 18 February 2008, the evaluating competent authority stated that the first applicant’s applications were incomplete due to severe lack of information.
89 At that time, the evaluating competent authority gave the first applicant until July 2013 to complete the dossier
90 It was only in 2015, and therefore almost eight years after the deadline, that the evaluating competent authority was able to state that the dossier was complete.
91 It follows that PHMB (1415; 4.7) was marketed for a much longer period than that envisaged by the EU legislature without that substance being approved in accordance with the applicable EU legislation, thus undermining the objective of ensuring a high level of protection for human health and the environment and the precautionary principle.
92 As regards the interests defended by the applicants, it is necessary to consider whether their interests may be affected in such a way as to tilt the balance in their favour.
93 In their arguments concerning the requirement of urgency, the applicants maintain that the contested measures would lead to loss of market share or even a risk of bankruptcy.
94 In that regard, it should be noted that, even though neither the production nor use of PHMB (1415; 4.7) are prohibited by the contested measures, there may, a priori, be a significant reduction in the use of that substance, which could also have not inconsiderable repercussions for production.
95 Accordingly, as regards the first applicant, which produces and sells only PHMB (1415; 4.7), the risk of considerable loss of market share cannot be ruled out.
96 On the other hand, as regards the claim that its financial viability is at risk, it is appropriate to bear in mind the case-law that such a risk must be assessed, where appropriate, having regard to the characteristics of the group to which the party seeking interim measures belongs, so that that party must produce, with supporting documentation, an accurate overall picture of its financial situation (see order of 29 February 2016, ICA Laboratories and Others v Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited; see also, to that effect, order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited).
97 The first applicant is held by a holding company and has not provided any information whatsoever on that company’s financial situation.
98 Accordingly, the first applicant has failed to provide an accurate overall picture of its financial situation, as required by case-law.
99 Furthermore, it should be noted that the first applicant states in its written pleadings that the combined effect of the contested measures will ‘with absolute certainty’ be that it will no longer be a viable undertaking, whereas the President and Chief Executive Officer of the first applicant describes the position in a much more qualified manner in paragraphs 18 and 19 of his affidavit of 28 May 2018.
100 In those circumstances, it cannot be concluded that the risk for the first applicant’s financial viability is established to the requisite degree.
101 As regards the second applicant, which produces and sells only PHMB (1415; 4.7)-based products and devices, the risk of considerable loss of market share or even of its bankruptcy cannot be discounted, for the reasons set out in paragraph 94 above, and because, according to the information given in the application for interim measures, it is a recently established company that does not form part of a group of companies and does not have significant financial resources.
102 Nevertheless, as regards the importance of the interests defended by the applicants, when weighing up the interests at stake it is necessary to bear in mind the case-relating to the requirement of urgency to the effect that, in a highly regulated market, such as that in the present case, it is for the undertakings concerned, if they are not to bear themselves the loss resulting from intervention by the authorities, to protect themselves against its consequences by adopting an appropriate policy (see, to that effect, order of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), not published, EU:C:2016:462, paragraph 29 and the case-law cited).
103 That case-law is also relevant for the purpose of weighing up the competing interests involved.
104 It is an inherent feature of the sector in which the applicants operate and thus of the legal situation of the applicants, which must have been aware of the risk that use of PHMB (1415; 4.7) might not be permitted for certain products or that its use for other products might be subject to certain restrictions, that the economic measures they took entailed a certain risk.
105 In that regard, the first applicant was aware, at the latest when Regulation No 2032/2003 was published in the Official Journal of the European Union on 24 November 2003, that PHMB (1415; 4.7) was to be evaluated. As regards the second applicant, it was established in 2014 and since then it has based its business on the use of PHMB (1415; 4.7), although, as a prudent operator in a highly regulated sector, it should have known that that substance was being evaluated.
106 In those circumstances, the risk of loss of market share or even, in the case of the second applicant, bankruptcy, cannot tilt the balance of interests in favour of the applicants. That similarly applies as regards the alleged loss of jobs. It should also be noted in that regard that the applicants have merely claimed that there will be job losses, without specifying or, a fortiori, demonstrating the nature of the jobs concerned or indeed the total number of people they employ.
107 Lastly, the examination of the requirement to establish a prima facie case has disclosed nothing to suggest that the balance of interests tilts in favour of the applicants in the present case.
108 It must therefore be concluded that the weighing up of the interests tilts the balance in favour of refusing the stay of operation of the contested measures and there are no grounds for considering, in the circumstances of the present case, that, in the words of Article 278 TFEU, those circumstances ‘require’ the Court to order that application of the contested measures be suspended.
109 It follows from all the foregoing that the applications for interim measures must be dismissed, without there being any need to examine the pleas of inadmissibility raised by the Commission with regard to the second applicant.
110 By virtue of Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. Cases T‑337/18 R and T‑347/18 R are joined for the purpose of the present order.
2. The applications for interim measures are dismissed.
3. The costs are reserved.
Luxembourg, 24 August 2018.